Do Endotypes Predict Response and Sequelae in OSA Patients

NCT04875364 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 201432
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Sleep Apnea, Obstructive; Sleep; Sleep Disorder

Keywords

sleep; sleep apnea; OSA; obstructive sleep apnea; lunesta; cpap; endotype; Eszopiclone

Outcome Measures

Primary Outcomes (2)

• Psychomotor Vigilance Test

  A 10-minutes, computerized reaction test asking subject to press a button every time a prompt appears. Faster times indicate better reactions and higher alertness.

  8 weeks

• Endothelial Dysfunction

  Using a device called EndoPAT for a non-invasive bloodflow measure before, during, and after 5-minutes of occlusion to one arm. Differences in EndoPAT results will be compared between treatments.

  8 weeks

Secondary Outcomes (14)

• Neurocognitive Assessment: NIH Toolbox

  8 weeks

• Epworth Sleepiness Scale (ESS)

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• Insomnia Severity Index (ISI)

  8 weeks

• Richard's Campbell Sleep Questionnaire (RCSQ)

  8 weeks

Study Arms (2)

Early PAP Start

EXPERIMENTAL

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.

Drug: Eszopiclone; Other: Supplemental Oxygen; Device: Continuous Positive Airway Pressure (CPAP)

Usual PAP Start

EXPERIMENTAL

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).

Drug: Eszopiclone; Other: Supplemental Oxygen

Interventions

Eszopiclone DRUG

2mg of Eszopiclone just before going to sleep.

Also known as: Lunesta

Early PAP Start; Usual PAP Start

Supplemental Oxygen OTHER

Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.

Early PAP Start; Usual PAP Start

Continuous Positive Airway Pressure (CPAP) DEVICE

A standard CPAP device will be provided using the settings as prescribed by the treating physician.

Early PAP Start

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 21-65 years old
• Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - \* see below)
• BMI 20 - 35 kg/m2

You may not qualify if:

• Pregnancy (current or planned)
• Nursing
• Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
• Already on effective therapy and adherent to treatment for OSA
• Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
• Circadian rhythm disorder
• Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
• Uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>95)
• Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
• Presence of tracheostomy
• Hospitalization within the past 90 days
• Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\< 5 years)
• Prior gastric bypass surgery
• Chronic liver disease or end-stage kidney disease
• Active cancer

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Altman Clinical and Translational Research Institute Building

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Wake Disorders; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Eszopiclone; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Atul Malhotra, MD

  Professor, Medicine

  PRINCIPAL INVESTIGATOR

• Christopher Schmickl

  Postdoc Fellow, Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela DeYoung

CONTACT

8582462154; pdeyoung@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: August 1, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (1)